Prescription Drug User Fee Act VI Commitment To Assess Current Practices of the Food and Drug Administration and Sponsors in Communicating During Investigational New Drug Development; Establishment of a Public Docket; Request for Comments, 57990-57991 [2017-26437]

Download as PDF sradovich on DSK3GMQ082PROD with NOTICES 57990 Federal Register / Vol. 82, No. 235 / Friday, December 8, 2017 / Notices Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public workshop must register by January 18, 2018, 4 p.m. Eastern Time. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted. If time and space permit, onsite registration on the day of the public workshop will be provided beginning at 7:30 a.m. We will let registrants know if registration closes before the day of the public workshop. 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Organizations are VerDate Sep<11>2014 20:38 Dec 07, 2017 Jkt 244001 requested to register all participants, but to view using one connection per location. If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/ help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit https://www.adobe.com/ go/connectpro_overview. FDA has verified the Web site addresses in this document, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time. Transcripts: Please be advised that as soon as a transcript of the public workshop is available, it will be accessible at https:// www.regulations.gov. It may be viewed at the Dockets Management Staff (see ADDRESSES). A link to the transcript will also be available on the Internet at https://www.fda.gov/MedicalDevices/ NewsEvents/WorkshopsConferences/ default.htm. IV. Reference The following reference is on display at the Dockets Management Staff (see ADDRESSES), and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also available electronically at https:// www.regulations.gov. FDA has verified the Web site addresses, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time. 1. FDA’s Digital Health Innovation Action Plan issued on July 27, 2017 available at: https://www.fda.gov/MedicalDevices/ DigitalHealth/UCM567265. Dated: December 4, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–26457 Filed 12–7–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–N–6313] Prescription Drug User Fee Act VI Commitment To Assess Current Practices of the Food and Drug Administration and Sponsors in Communicating During Investigational New Drug Development; Establishment of a Public Docket; Request for Comments AGENCY: Food and Drug Administration, HHS. PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 Notice; establishment of a public docket; request for comments. ACTION: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the statement of work to assess current practices of FDA and sponsors in communicating during investigational new drug (IND) development and identify best practices and areas of improvement. The independent assessment is part of FDA performance commitments under the recent reauthorization of the Prescription Drug User Fee Act (PDUFA). The independent assessment of current practices of FDA and sponsors in communicating during drug development is described in detail in the document entitled ‘‘PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2018 Through 2022’’ available at https://www.fda.gov/ downloads/forindustry/userfees/ prescriptiondruguserfee/ ucm511438.pdf. As part of FDA performance commitments described in this document, the assessment will be conducted by an independent contractor. FDA is providing for public comment on the statement of work before revising and requesting contractor proposals. DATES: Submit either electronic or written comments by January 22, 2018. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before January 22, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of January 22, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. You may submit comments as follows: SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, E:\FR\FM\08DEN1.SGM 08DEN1 Federal Register / Vol. 82, No. 235 / Friday, December 8, 2017 / Notices sradovich on DSK3GMQ082PROD with NOTICES such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2017–N–6313 for ‘‘Prescription Drug User Fee Act VI Commitment to Assess Current Practices of the Food and Drug Administration and Sponsors in Communicating During Investigational New Drug Development.’’ Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management VerDate Sep<11>2014 20:38 Dec 07, 2017 Jkt 244001 Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Yoni Tyberg, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1151, Silver Spring, MD 20993, 301–348–1718, Fax: 301– 847–8443, Yonatan.Tyberg@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background The IND phase of drug development is the time during which human trials of investigational drugs are conducted. During the IND phase, sponsors and FDA engage in many types of communications. To ensure the effectiveness of human drug review programs, it is critical that these communications be conducted in a timely and efficient manner. The timely review of the safety and effectiveness of new drugs and biologics is central to FDA’s mission to protect and promote the public health. Prior to enactment of PDUFA in 1992, FDA’s drug review process was relatively slow and not very predictable compared to that of other countries. Due to concerns expressed by both industry and patients at the time, Congress enacted PDUFA, which provided the added funds through user fees that enabled FDA to hire additional reviewers and support staff and upgrade its information technology systems. In return for additional resources, FDA agreed to certain review performance goals, such as completing reviews of new drug applications and biologics license applications and taking regulatory PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 57991 actions on them in predictable timeframes. These changes revolutionized the drug approval process in the United States and enabled FDA to speed the application review process for new drugs and biologics without compromising the Agency’s high standards for demonstration of safety, efficacy, and quality of new drugs and biologics prior to approval. PDUFA provides FDA with a source of stable, consistent funding that has made it possible for it to focus on promoting innovative therapies and help bring to market critical products for patients. When PDUFA was originally authorized in 1992, it had a 5-year term. The program has been subsequently reauthorized every 5 years with the most recent reauthorization occurring in 2017 for fiscal years (FYs) 2018–2022. To prepare for the 2017 reauthorization of PDUFA, FDA conducted negotiations with the regulated industry and held regular consultations with public stakeholders including patient advocates, consumer advocates, and health care professionals between September 2015 and February 2016. Following these discussions, related public meetings, and Agency requests for public comment, FDA published proposed recommendations for PDUFA VI for FYs 2018–2022. FDA committed under PDUFA VI to contract with an independent third party to assess current practices of FDA and sponsors in communicating during IND development and to identify best practices and areas of improvement. The statement of work can be accessed at https://www.fda.gov/ downloads/ForIndustry/UserFees/ PrescriptionDrugUserFee/ UCM577087.pdf. Dated: December 4, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–26437 Filed 12–7–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–D–6294] Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: E:\FR\FM\08DEN1.SGM Notice of availability. 08DEN1

Agencies

[Federal Register Volume 82, Number 235 (Friday, December 8, 2017)]
[Notices]
[Pages 57990-57991]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26437]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6313]


Prescription Drug User Fee Act VI Commitment To Assess Current 
Practices of the Food and Drug Administration and Sponsors in 
Communicating During Investigational New Drug Development; 
Establishment of a Public Docket; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; establishment of a public docket; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the statement of work to assess 
current practices of FDA and sponsors in communicating during 
investigational new drug (IND) development and identify best practices 
and areas of improvement. The independent assessment is part of FDA 
performance commitments under the recent reauthorization of the 
Prescription Drug User Fee Act (PDUFA). The independent assessment of 
current practices of FDA and sponsors in communicating during drug 
development is described in detail in the document entitled ``PDUFA 
Reauthorization Performance Goals and Procedures Fiscal Years 2018 
Through 2022'' available at https://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm511438.pdf. As part of FDA 
performance commitments described in this document, the assessment will 
be conducted by an independent contractor. FDA is providing for public 
comment on the statement of work before revising and requesting 
contractor proposals.

DATES: Submit either electronic or written comments by January 22, 
2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before January 22, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of January 22, 2018. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted,

[[Page 57991]]

such as medical information, your or anyone else's Social Security 
number, or confidential business information, such as a manufacturing 
process. Please note that if you include your name, contact 
information, or other information that identifies you in the body of 
your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2017-N-6313 for ``Prescription Drug User Fee Act VI Commitment to 
Assess Current Practices of the Food and Drug Administration and 
Sponsors in Communicating During Investigational New Drug 
Development.'' Received comments, those filed in a timely manner (see 
ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Yoni Tyberg, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 1151, Silver Spring, MD 20993, 301-348-
1718, Fax: 301-847-8443, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    The IND phase of drug development is the time during which human 
trials of investigational drugs are conducted. During the IND phase, 
sponsors and FDA engage in many types of communications. To ensure the 
effectiveness of human drug review programs, it is critical that these 
communications be conducted in a timely and efficient manner.
    The timely review of the safety and effectiveness of new drugs and 
biologics is central to FDA's mission to protect and promote the public 
health. Prior to enactment of PDUFA in 1992, FDA's drug review process 
was relatively slow and not very predictable compared to that of other 
countries. Due to concerns expressed by both industry and patients at 
the time, Congress enacted PDUFA, which provided the added funds 
through user fees that enabled FDA to hire additional reviewers and 
support staff and upgrade its information technology systems. In return 
for additional resources, FDA agreed to certain review performance 
goals, such as completing reviews of new drug applications and 
biologics license applications and taking regulatory actions on them in 
predictable timeframes. These changes revolutionized the drug approval 
process in the United States and enabled FDA to speed the application 
review process for new drugs and biologics without compromising the 
Agency's high standards for demonstration of safety, efficacy, and 
quality of new drugs and biologics prior to approval.
    PDUFA provides FDA with a source of stable, consistent funding that 
has made it possible for it to focus on promoting innovative therapies 
and help bring to market critical products for patients. When PDUFA was 
originally authorized in 1992, it had a 5-year term. The program has 
been subsequently reauthorized every 5 years with the most recent 
reauthorization occurring in 2017 for fiscal years (FYs) 2018-2022. To 
prepare for the 2017 reauthorization of PDUFA, FDA conducted 
negotiations with the regulated industry and held regular consultations 
with public stakeholders including patient advocates, consumer 
advocates, and health care professionals between September 2015 and 
February 2016. Following these discussions, related public meetings, 
and Agency requests for public comment, FDA published proposed 
recommendations for PDUFA VI for FYs 2018-2022. FDA committed under 
PDUFA VI to contract with an independent third party to assess current 
practices of FDA and sponsors in communicating during IND development 
and to identify best practices and areas of improvement.
    The statement of work can be accessed at https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM577087.pdf.

    Dated: December 4, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26437 Filed 12-7-17; 8:45 am]
 BILLING CODE 4164-01-P
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